tbuckley/cabot-search huggingface dataset:
Real-world effectiveness of digital and group-based lifestyle interventions as compared with usual care to reduce type 2 diabetes risk – A stop diabetes pragmatic randomised trial
Authors: Timo A. Lakka, Kirsikka Aittola, Elina Järvelä-Reijonen, Tanja Tilles-Tirkkonen, Reija Männikkö, Niina Lintu, Leila Karhunen, Marjukka Kolehmainen, Marja Harjumaa, Elina Mattila, Riia Järvenpää, Miikka Ermes, Santtu Mikkonen, Janne Martikainen, Kaisa Poutanen, Ursula Schwab, Pilvikki Absetz, Jaana Lindström, Jussi Pihlajamäki
Journal: The Lancet Regional Health - Europe (2022)

No real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D).We conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18-74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478.The 2907 participants assigned were recruited between March 1st, 2017, and February 28th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p<0·001 for difference between groups, p'<0·001 for group*time interaction) and waist circumference tended to decrease more (-1·8 vs. -1·3 cm, p = 0·028, p' = 0·068) in DIGI+GROUP than in CONTROL. Fasting insulin tended to increase in CONTROL but not in DIGI (1·0 vs. 0·0 mU/L, p = 0·033, p' = 0·054) or in DIGI+GROUP (1·0 vs. 0·5 mU/L, p = 0·042, p' = 0·054). Good adherence to DIGI and DIGI+GROUP (≥median of 501 habits/year in DIGI, ≥5 of all 6 sessions in GROUP) was associated with improved diet quality and good adherence to DIGI with increased physical activity and decreased sedentary time.A lifestyle intervention based on multiple behaviour change theories and combined digital and group-based face-to-face delivery improves diet quality and tends to decrease abdominal adiposity and prevent an increase in insulin resistance. Good adherence improves the results of the interventions.Strategic Research Council at Academy of Finland, Academy of Finland, Novo Nordisk Foundation, and Finnish Diabetes Research foundation.
Occult recurrent breast cancer masquerading as thrombotic thrombocytopenic purpura
Authors: Beatriz Wills‐Sanin, James N. George, Leonardo Boiocchi, Gerald A. Soff, Jodi V. Mones
Journal: American Journal of Hematology (2022)

GATA3 immunohistochemistry stain of the bone marrow biopsy required to diagnose recurrent metastatic breast cancer.
Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial
Authors: William J Sandborn, Julian Panés, Silvio Danese, Zaineb Sharafali, Azra Hassanali, Rhian Jacob-Moffatt, Christopher Eden, Marco Daperno, John F Valentine, David Laharie, Carolina Baía, Raja Atreya, Remo Panaccione, Grazyna Rydzewska, Humberto Aguilar, Séverine Vermeire
Journal: The Lancet. Gastroenterology & hepatology (2022)
A low-cost genomics workflow enables isolate screening and strain-level analyses within microbiomes
Authors: Jon G. Sanders, Weiwei Yan, Deus Mjungu, Elizabeth V. Lonsdorf, John A. Hart, Crickette M. Sanz, David B. Morgan, Martine Peeters, Beatrice H. Hahn, Andrew H. Moeller
Journal: Genome biology (2022)

Abstract Earth’s environments harbor complex consortia of microbes that affect processes ranging from host health to biogeochemical cycles. Understanding their evolution and function is limited by an inability to isolate genomes in a high-throughput manner. Here, we present a workflow for bacterial whole-genome sequencing using open-source labware and the OpenTrons robotics platform, reducing costs to approximately $10 per genome. We assess genomic diversity within 45 gut bacterial species from wild-living chimpanzees and bonobos. We quantify intraspecific genomic diversity and reveal divergence of homologous plasmids between hosts. This enables population genetic analyses of bacterial strains not currently possible with metagenomic data alone.
Dual tumor- and subcellular-targeted photodynamic therapy using glucose-functionalized MoS2 nanoflakes for multidrug-resistant tumor ablation
Authors: Shaohui Xu, Pan Zhang, Isabelle Heing-Becker, Junmei Zhang, Peng Tang, Raju Bej, Sumati Bhatia, Yinan Zhong, Rainer Haag
Journal: Biomaterials (2022)
Therapy-Induced Senescence Enhances the Efficacy of HER2-Targeted Antibody–Drug Conjugates in Breast Cancer
Authors: Santiago Duro-Sánchez, Mercedes Nadal-Serrano, Marta Lalinde-Gutiérrez, Enrique Javier Arenas, Cristina Bernadó Morales, Beatriz Morancho, Marta Escorihuela, Sandra Pérez-Ramos, Santiago Escrivá-de-Romaní, Lucía Gandullo-Sánchez, Atanasio Pandiella, Anna Esteve-Codina, Verónica Rodilla, Fred A. Dijcks, Wim H.A. Dokter, Javier Cortés, Cristina Saura, Joaquín Arribas
Journal: Cancer Research (2022)

Antibody-drug conjugates (ADC) are antineoplastic agents recently introduced into the antitumor arsenal. T-DM1, a trastuzumab-based ADC that relies on lysosomal processing to release the payload, is approved for HER2-positive breast cancer. Next-generation ADCs targeting HER2, such as [vic-]trastuzumab duocarmazine (SYD985), bear linkers cleavable by lysosomal proteases and membrane-permeable drugs, mediating a bystander effect by which neighboring antigen-negative cells are eliminated. Many antitumor therapies, like DNA-damaging agents or CDK4/6 inhibitors, can induce senescence, a cellular state characterized by stable cell-cycle arrest. Another hallmark of cellular senescence is the enlargement of the lysosomal compartment. Given the relevance of the lysosome to the mechanism of action of ADCs, we hypothesized that therapies that induce senescence would potentiate the efficacy of HER2-targeting ADCs. Treatment with the DNA-damaging agent doxorubicin and CDK4/6 inhibitor induced lysosomal enlargement and senescence in several breast cancer cell lines. While senescence-inducing drugs did not increase the cytotoxic effect of ADCs on target cells, the bystander effect was enhanced when HER2-negative cells were cocultured with HER2-low cells. Knockdown experiments demonstrated the importance of cathepsin B in the enhanced bystander effect, suggesting that cathepsin B mediates linker cleavage. In breast cancer patient-derived xenografts, a combination treatment of CDK4/6 inhibitor and SYD985 showed improved antitumor effects over either treatment alone. These data support the strategy of combining next-generation ADCs targeting HER2 with senescence-inducing therapies for tumors with heterogenous and low HER2 expression.Combining ADCs against HER2-positive breast cancers with therapies that induce cellular senescence may improve their therapeutic efficacy by facilitating a bystander effect against antigen-negative tumor cells.
PRC2-Mediated Epigenetic Suppression of Type I IFN-STAT2 Signaling Impairs Antitumor Immunity in Luminal Breast Cancer
Authors: Juyeong Hong, Ji Hoon Lee, Zhao Zhang, Yanming Wu, Mei Yang, Yiji Liao, Richard de la Rosa, Jessica Scheirer, Douglas Pechacek, Nu Zhang, Zhenming Xu, Tyler Curiel, Xi Tan, Tim H.-M. Huang, Kexin Xu
Journal: Cancer Research (2022)

Abstract The immunosuppressive tumor microenvironment in some cancer types, such as luminal breast cancer, supports tumor growth and limits therapeutic efficacy. Identifying approaches to induce an immunostimulatory environment could help improve cancer treatment. Here, we demonstrate that inhibition of cancer-intrinsic EZH2 promotes antitumor immunity in estrogen receptor α–positive (ERα+) breast cancer. EZH2 is a component of the polycomb-repressive complex 2 (PRC2) complex, which catalyzes trimethylation of histone H3 at lysine 27 (H3K27me3). A 53-gene PRC2 activity signature was closely associated with the immune responses of ERα+ breast cancer cells. The stimulatory effects of EZH2 inhibition on immune surveillance required specific activation of type I IFN signaling. Integrative analysis of PRC2-repressed genes and genome-wide H3K27me3 landscape revealed that type I IFN ligands are epigenetically silenced by H3K27me3. Notably, the transcription factor STAT2, but not STAT1, mediated the immunostimulatory functions of type I IFN signaling. Following EZH2 inhibition, STAT2 was recruited to the promoters of IFN-stimulated genes even in the absence of the cytokines, suggesting the formation of an autocrine IFN-STAT2 axis. In patients with luminal breast cancer, high levels of EZH2 and low levels of STAT2 were associated with the worst antitumor immune responses. Collectively, this work paves the way for the development of an effective therapeutic strategy that may reverse immunosuppression in cancer. Significance: Inhibition of EZH2 activates a type I IFN-STAT2 signaling axis and provides a therapeutic strategy to stimulate antitumor immunity and therapy responsiveness in immunologically cold luminal breast cancer.
Taiwan Biobank: A rich biomedical research database of the Taiwanese population
Authors: Yen-Chen Anne Feng, Chia-Yen Chen, Tzu-Ting Chen, Po-Hsiu Kuo, Yi-Hsiang Hsu, Hwai-I Yang, Wei J. Chen, Ming-Wei Su, Hou-Wei Chu, Chen-Yang Shen, Tian Ge, Hailiang Huang, Yen-Feng Lin
Journal: Cell Genomics (2022)

The Taiwan Biobank (TWB) is an ongoing prospective study of >150,000 individuals aged 20-70 in Taiwan. A comprehensive list of phenotypes was collected for each consented participant at recruitment and follow-up visits through structured interviews and physical measurements. Biomarkers and genetic data were generated from blood and urine samples. We present here an overview of TWB's genetic data quality, population structure, and familial relationship, which consists of predominantly Han Chinese ancestry, and highlight its important attributes and genetic findings thus far. A linkage to Taiwan's National Health Insurance database of >25 years and other registries is underway to enrich the phenotypic spectrum and enable deep and longitudinal genetic investigations. TWB provides one of the largest biobank resources for biomedical and public health research in East Asia that will contribute to our understanding of the genetic basis of health and disease in global populations through collaborative studies with other biobanks.
Efficacy of Adjunctive <scp>D</scp>-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder
Authors: Jaeden Cole, Maya N. Sohn, Ashley D. Harris, Signe L. Bray, Scott B. Patten, Alexander McGirr
Journal: JAMA Psychiatry (2022)

The antidepressant effects of transcranial magnetic stimulation protocols for major depressive disorder (MDD) are thought to depend on synaptic plasticity. The theta-burst stimulation (TBS) protocol synaptic plasticity is known to be N-methyl-D-aspartate (NMDA)-receptor dependent, yet it is unknown whether enhancing NMDA-receptor signaling improves treatment outcomes in MDD.To test whether low doses of the NMDA-receptor partial-agonist, D-cycloserine, would enhance intermittent TBS (iTBS) treatment outcomes in MDD.This was a single-site 4-week, double-blind, placebo-controlled, randomized clinical trial conducted from November 6, 2019, to December 24, 2020, including 50 participants with MDD. Participants were recruited via advertisements and referral. Inclusion criteria were as follows: age 18 to 65 years with a primary diagnosis of MDD, a major depressive episode with score of 18 or more on the 17-item Hamilton Depression Rating Scale, a Young Mania Rating Scale score of 8 or less, and normal blood work (including complete blood cell count, electrolytes, liver function tests, and creatinine level).Participants were randomly assigned 1:1 to either iTBS plus placebo or iTBS plus D-cycloserine (100 mg) for the first 2 weeks followed by iTBS without an adjunct for weeks 3 and 4.The primary outcome was change in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at the conclusion of treatment. Secondary outcomes included clinical response, clinical remission, and Clinical Global Impression (CGI) scores.A total of 50 participants (mean [SD] age, 40.8 [13.4] years; 31 female [62%]) were randomly assigned to treatment groups: iTBS plus placebo (mean [SD] baseline score, 30.3 [4.2]) and iTBS plus D-cycloserine (mean [SD] baseline score, 30.4 [4.5]). The iTBS plus D-cycloserine group had greater improvements in MADRS scores compared with the iTBS plus placebo group (mean difference, -6.15; 95% CI, -2.43 to -9.88; Hedges g = 0.99; 95% CI, 0.34-1.62). Rates of clinical response were higher in the iTBS plus D-cycloserine group than in the iTBS plus placebo group (73.9% vs 29.3%), as were rates of clinical remission (39.1% vs 4.2%). This was reflected in lower CGI-severity ratings and greater CGI-improvement ratings. No serious adverse events occurred.Findings from this clinical trial indicate that adjunctive D-cycloserine may be a promising strategy for enhancing transcranial magnetic stimulation treatment outcomes in MDD using iTBS requiring further investigation.ClinicalTrials.gov Identifier: NCT03937596.
Leveraging global multi-ancestry meta-analysis in the study of idiopathic pulmonary fibrosis genetics
Authors: Juulia J. Partanen, Paavo Häppölä, Wei Zhou, Arto A. Lehisto, Mari Ainola, Eva Sutinen, Richard J. Allen, Amy D. Stockwell, Olivia C. Leavy, Justin M. Oldham, Beatriz Guillen-Guio, Nancy J. Cox, Jibril B. Hirbo, David A. Schwartz, Tasha E. Fingerlin, Carlos Flores, Imre Noth, Brian L. Yaspan, R. Gisli Jenkins, Louise V. Wain, Samuli Ripatti, Matti Pirinen, Tarja Laitinen, Riitta Kaarteenaho, Marjukka Myllärniemi, Mark J. Daly, Jukka T. Koskela
Journal: Cell Genomics (2022)
Obesity caused by an OVOL2 mutation reveals dual roles of OVOL2 in promoting thermogenesis and limiting white adipogenesis
Authors: Zhao Zhang, Yiao Jiang, Lijing Su, Sara Ludwig, Xuechun Zhang, Miao Tang, Xiaohong Li, Priscilla Anderton, Xiaoming Zhan, Mihwa Choi, Jamie Russell, Chun-Hui Bu, Stephen Lyon, Darui Xu, Sara Hildebrand, Lindsay Scott, Jiexia Quan, Rochelle Simpson, Qihua Sun, Baifang Qin, Tiffany Collie, Meron Tadesse, Eva Marie Y. Moresco, Bruce Beutler
Journal: Cell Metabolism (2022)
In vitro neurons learn and exhibit sentience when embodied in a simulated game-world
Authors: Brett J. Kagan, Andy C. Kitchen, Nhi T. Tran, Forough Habibollahi, Moein Khajehnejad, Bradyn J. Parker, Anjali Bhat, Ben Rollo, Adeel Razi, Karl J. Friston
Journal: Neuron (2022)

Integrating neurons into digital systems may enable performance infeasible with silicon alone. Here, we develop DishBrain, a system that harnesses the inherent adaptive computation of neurons in a structured environment. In vitro neural networks from human or rodent origins are integrated with in silico computing via a high-density multielectrode array. Through electrophysiological stimulation and recording, cultures are embedded in a simulated game-world, mimicking the arcade game "Pong." Applying implications from the theory of active inference via the free energy principle, we find apparent learning within five minutes of real-time gameplay not observed in control conditions. Further experiments demonstrate the importance of closed-loop structured feedback in eliciting learning over time. Cultures display the ability to self-organize activity in a goal-directed manner in response to sparse sensory information about the consequences of their actions, which we term synthetic biological intelligence. Future applications may provide further insights into the cellular correlates of intelligence.
Is CABG Indicated in Patients With Ischemic Cardiomyopathy?
Authors: Eric R. Bates
Journal: JAMA Cardiology (2022)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Cardiology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Cardiology journal
hENT1 Expression Predicts Response to Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Ductal Adenocarcinoma
Authors: Sheron Perera, Gun Ho Jang, Yifan Wang, Deirdre Kelly, Michael Allen, Amy Zhang, Robert E. Denroche, Anna Dodd, Stephanie Ramotar, Shawn Hutchinson, Mustapha Tehfe, Ravi Ramjeesingh, James Biagi, Bernard Lam, Julie Wilson, Sandra E. Fischer, George Zogopoulos, Faiyaz Notta, Steven Gallinger, Robert C. Grant, Jennifer J. Knox, Grainne M. O'Kane
Journal: Clinical Cancer Research (2022)

Modified FOLFIRINOX (mFFX) and gemcitabine/nab-paclitaxel (GnP) remain standard first-line options for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Human equilibrative nucleoside transporter 1 (hENT1) was hypothesized to be a biomarker of gemcitabine in the adjuvant setting, with conflicting results. In this study, we explore hENT1 mRNA expression as a predictive biomarker in advanced PDAC.COMPASS was a prospective observational trial of patients with advanced PDAC. A biopsy was required prior to initiating chemotherapy, as determined by treating physician. Biopsies underwent laser capture microdissection prior to whole genome and RNA sequencing. The cut-off thresholds for hENT1 expression were determined using the maximal χ2 statistic.253 patients were included in the analyses with a median follow-up of 32 months, with 138 patients receiving mFFX and 92 receiving GnP. In the intention to treat population, median overall survival (OS) was 10.0 months in hENT1high versus 7.9 months in hENT1low (P = 0.02). In patients receiving mFFX, there was no difference in overall response rate (ORR; 35% vs. 28%, P = 0.56) or median OS (10.6 vs. 10.5 months, P = 0.45). However, in patients treated with GnP, the ORR was significantly higher in hENT1high compared with hENT1low tumors (43% vs. 21%, P = 0.038). Median OS in this GnP-treated cohort was 10.6 months in hENT1high versus 6.7 months hENT1low (P < 0.001). In an interaction analysis, hENT1 was predictive of treatment response to GnP (interaction P = 0.002).In advanced PDAC, hENT1 mRNA expression predicts ORR and OS in patients receiving GnP.
SOX18 Targeting as a Potential, Viable Therapeutic Avenue for Kaposi Sarcoma—Reply
Authors: Rafael Salido-Vallejo, Agustín España
Journal: JAMA Dermatology (2022)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Dermatology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Dermatology journal
Outcomes of COVID-19 and Vaccination in Patients With Moderate to Severe Atopic Dermatitis Treated With Tralokinumab
Authors: Andrew Blauvelt, Andrew Pink, Margitta Worm, Richard G. B. Langley, Boni E. Elewski, Le Gjerum, Emma Guttman-Yassky
Journal: JAMA Dermatology (2022)

This case series describes the outcomes of COVID-19 and SARS-CoV-2 vaccination in patients with atopic dermatitis who have been treated with tralokinumab.
Safety, Outcomes, and T-Cell Characteristics in Patients with Relapsed or Refractory MDS or CMML Treated with Atezolizumab in Combination with Guadecitabine
Authors: Casey L. O'Connell, Maria R. Baer, Andreas Due Ørskov, Sunil Kumar Saini, Vu H. Duong, Patricia Kropf, Jakob Werner Hansen, Denice Tsao-Wei, Hyo Sik Jang, Ashkan Emadi, Staffan Holmberg-Thyden, Jack Cowland, Brett T. Brinker, Kristin Horwood, Ryan Burgos, Galen Hostetter, Benjamin A. Youngblood, Sine Reker Hadrup, Jean-Pierre Issa, Peter Jones, Stephen B. Baylin, Imran Siddiqi, Kirsten Grønbaek
Journal: Clinical Cancer Research (2022)

Abstract Purpose: We hypothesized that resistance to hypomethylating agents (HMA) among patients with myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) would be overcome by combining a programmed death-ligand 1 antibody with an HMA. Patients and Methods: We conducted a Phase I/II, multicenter clinical trial for patients with MDS not achieving an International Working Group response after at least 4 cycles of an HMA (“refractory”) or progressing after a response (“relapsed”) with 3+ or higher risk MDS by the revised International Prognostic Scoring System (IPSS-R) and CMML-1 or -2. Phase I consisted of a 3+3 dose-escalation design beginning with guadecitabine at 30 mg/m2 and escalating to 60 mg/m2 Days 1 to 5 with fixed-dose atezolizumab: 840 mg intravenously Days 8 and 22 of a 28-day cycle. Primary endpoints were safety and tolerability; secondary endpoints were overall response rate (ORR) and survival. Results: Thirty-three patients, median age 73 (range 54–85), were treated. Thirty patients had MDS and 3 had CMML, with 30% relapsed and 70% refractory. No dose-limiting toxicities were observed in Phase I. There were 3 (9%) deaths in ≤ 30 days. Five patients (16%) came off study for drug-related toxicity. Immune-related adverse events (IRAE) occurred in 12 (36%) patients (4 grade 3, 3 grade 2, and 5 grade1). ORR was 33% [95% confidence interval (CI), 19%–52%] with 2 complete remission (CR), 3 hematologic improvement, 5 marrow CR, and 1 partial remission. Median overall survival was 15.1 (95% CI, 8.5–25.3) months. Conclusions: Guadecitabine with atezolizumab has modest efficacy with manageable IRAEs and typical cytopenia-related safety concerns for patients with relapsed or refractory MDS and CMML.